Intra-uterine contraceptive device



Aug. 20, 1968 G. MAJZLIN 3,397,691

INTRA-UTERINE CONTRACEPTIVE DEVICE Filed June 2, 1966 INVENTOR.

GREGORY MAJZLIN ATTORNEYS gwmwzxm United States Patent 3,397,691INTRA-UTERINE CONTRACEPTIVE DEVICE Gregory Majzliu, 92 Whitman Drive,Brooklyn, N.Y. 11234 Filed June 2, 1966, Ser. No. 554,765 9 Claims. (Cl.128-130) The present invention relates to an improved intrauterinecontraceptive device and more specifically to an intra-uterinecontraceptive device which can be readily inserted into the uterus by aphysician without having to anesthetize the patient, is retained in theuterus with greater security notwithstanding the expulsive force of theuterine muscular contractions and is. readily removed from the uterus,after it is no longer required, without having to subject the user tothe painful process of dilating the cervical canal.

There are many instances where a woman should not bear any more childrenbecause it would be detrimental to her health or in some cases fatal.Doctors have prescribed for these women patients one of many types ofcontraceptive devices or drugs which are now sold commercially. However,all of these devices or drugs require a strict time schedule of usewhich too often is ignored by the patient, resulting in a medicallyinadvisable pregnancy. Further, many women react adversely tocontraceptive drugs and therefore cannot use them.

Because of the disadvantages of the above devices there has been aconsiderable search for a contraceptive device which can be effectivelyused without adhering to a time schedule and which is not toxic to thehuman system. One such device is the intra-uterine contraceptive device.This device works on the known principle that placing a foreign objectin the uterus will prevent conception or implantation of the fertilizedovum. Therefore as long as the device remains in the uterus pregnancycan be avoided.

There have been many intra-uterine contraceptive devices designed andmany of these are now in use. However, one of the major drawbacks ofthese devices is that they are prone to be expelled from the uterus,usually without the woman being aware of it. Applicant has solved thisproblem with a device which takes advantage of the uterine contractionsfor holding it in place and which is described in copendng applicationSer. No. 510,- 752 filed Dec. 1, 1965. However, although the device ofthe aforesaid application works successfully, it has been found that insome cases there is some difiiculty in inserting and removing thedevice.

The present invention provides an improvement of the former device inthat the new device can be readily removed without dilating the cervicalcanal and surprisingly still uses to advantage the uterine contractionsfor retaining it in place.

The device of the present invention is the nature of a spring memberhaving a general structure analogous to a spiral spring with a number ofwindings. The spring member is emplaced within the uterus in suchposition that the windings thereof expand and contract between the sidesof the uterus.

When a foreign object in general is inserted into the uterus, the uteruswill automatically start its muscular contractions. The muscularcontractions occur in two sequential steps. The first muscularcontraction occurs in the cervico-isthmal region of the uterus where themuscle fibers are arranged in circular fashion. This causes the walls ofthe uterus to approach each other and squeeze any foreign object in thatregion. The second muscular contraction occurs at the fundus where themuscle fibers are arranged in a generally longitudinal direction. Thegenerally longitudinal arrangement of the muscle fibers results in adownward squeezing force which ordinarily tends to cause expulsion of aforeign object such as a conventional intra-uterine contraceptivedevice. The fundue contraction is analogous to squeezing a large ball bythe palm and fingers of a hand.

'As explained above the spring member of the present invention isarranged to expand and contract between the sides of the uterus and isinitially placed in the cervicoisthmal region. As a result, the muscularcontractions of the cervico-isthmal region begin and the pressurethereof is exerted against the bottom portions of the windings of thespring member to cause these portions to compress. The spring memberwill resist being compressed and because the compressing force isapplied substantially along only the bottom portions of the windings,there results a camming action that tends to move the spring memberupwardly towards the fundus or top of the uterine cavity. After themuscles of the cervico-isthmal region relax, the muscle fibers of thefundus will start to contract. The contraction of the fundus mucles willexert pressure against the top portions of the windings of the springmember, causing these portions to compress. As the top portions of thewindings become compressed, the bottom portions of the windings spreadapart in an outward direction like the spreading of a fan. Thisspreading of the bottom portions of the windings is a very efficientaction and of great advantage for securely retaining the spring memberin the uterus as will be explained in greater detail below.

Another advantage of the spring member of the present application isthat its windings trace a relatively large volume so that the springmember occupies a greater portion of the volume of the uterine cavitythan existing intra-uterine devices. This is important since thecontraceptive effect is believed to be directly related to how much ofthe uterine cavity is occupied by a contraceptive device, and the springmember of the present invention definitely provides a considerableimprovement in this respect over conventional devices.

As mentioned above, the spring member of the invention is generallyanalogous to a spiral spring, and has a plurality :of windings whichtrace a three-dimensional volume containing a central axis of expansionand contraction. The windings are free to expand and contract along axesgenerally parallel to the central axis. The maximum distance betweenopposite windings of the spring member, measured perpendicularly to thecentral axis of expansion and contraction, has a critical predetermineddimension which will allow the spring member when entirely compressed topass through the cervical canal of the intended user for emplacement inthe uterus. It is essential that this perpendicular distance betweenopposite sides of the windings be sufliciently limited to allow thecompressed spring member to pass through the cervical canal withoutcausing injury to the intended user. For best results, the perpendiculardistance is sufficiently limited to allow the compressed spring memberto pass through the cervical canal without having to dilate the canalopening, and this in turn will allow emplacement and removal of thespring member without causing pain or discomfort to the intended userand without use of anesthetics. Generally speaking, the maximum usefuldimension for the distance across opposite windings will beapproximately 4.5 mm., there being some leeway in this limit dependingupon the specific anatomical capability of the intended user to receivethe spring member via the cervical canal without injury. For bestresults, the distance across opposite windings should be controlledwithin the range from about 1.to about 3 mm. since at least one of suchdimensions can be passed through the cervical canal of virtually allwomen without causing dilation, pain and discomfort, the average canalbeing about 2-4 mm. across its opening.

The distance between the ends of the spring member when compressed,measured parallel to the central axis of expansion and contraction, mustalso be sufliciently limited to allow the compress-ed member to passthrough the cervical canal. The maximum useful dimension for thedistance between the ends of the spring member when compressed will beapproximately 4.5 mm., although this dimension will vary also dependingupon the specific anatomical capability of the user. As in the case ofthe preferred distance between the windings of the spring member,measured perpendicular to the axis of expansion and contraction, thedistance between the ends of the compressed spring member, measuredparallel to the axis of expansion and contraction, should also becontrolled for best results, within the range of about 1.0 mm. to about3 mm.

After the spring member passes through the cervical canal and reachesthe uterine cavity, the windings of the spring member expand as much asthe sides of the uterine cavity permit and, because of the previouslymentioned fan-spreading action when the fundus muscles exert pressure onthe top portions of the expanded windings, the expanded spring memberwill thereafter remain in place in the uterus without any tendency forexpulsion.

A further advantage of the spring member of the invention is the factthat there is no possibility of the spring member becoming embedded inor perforating the uterine walls. Basically, the reason for this is thespring member does not rely on being wedged against the uterine walls tohold it in place as do conventional devices, but rather makes use of thefundus contractions to fan out the lower portions of its windings tohold itself in place in the uterus. The entire action is resilient andadjustable as compared to a wedge which does not yield in any way to themuscular contractions.

As for removing the spring member, this is readily accomplished byproviding the spring member with a draw string or loop passing throughthe interior of the volume traced by the windings, whereby the string orloop can be pulled in a direction away from the uterus to compress thelower portions of the windings for easy passage down through thecervical canal. This removal is convenient and substantially painlesswhen the dimensions across opposite windings of the spring member andthe dimensions across the ends of the spring member when compressed aresuitably selected for best results as previously described.

The spring member can be made from any plastic or metal resilientmaterial which will not lose its resiliency when sterilized and is notinjurious to living tissue. It has been found that excellent results canbe obtained when the spring member is constructed of spring-temperedstainless steel. This material is very resilient, is not injur ous toliving tissue, and has a very long coefiicient of friction. The latterproperty is important because, as previously mentioned, when thecervico-isthmal region of the uterus contracts, the spring member isforced to move up towards the fundus region of the uterus. If thematerial from which the spring member is made has a high coefiicient offriction, there will be excessive rubbing against the uterine wallswhich can cause damage to the tissue. Stainless steel will readily slidealong the uterine wall and prevent any damage to the tissue.

These and other features of the present invention are best understood byreference to the following drawings which show a preferred embodiment ofthe invention and of which:

FIG. 1 shows a preferred embodiment of the spring member of theinvention in expanded position prior to insertion into the uterus;

FIG. 2 shows the spring member of FIG. 1 inserted in the uterus withouta muscular contraction in the uterus; and

FIG 3 shows the spring member ofFIG. 1 in the uterus with the muscles ofthe fundus in a contraction.

The spring member 10 of FIG. 1 is made of stainless steel and has theconfiguration of a spiral spring which has been somewhat flattenedwhereby the windings 12 trace a three dimensional volume of a generallyrectangular cross section. Each winding 12 is composed of two arms 14and 16 which are connected at bends 18. The arms 14 and 16 forming thewindings 12 trace generally parallel planes which in conjunction withthe bends 18 form an imaginary rectangular solid which contains acentral axis 17 of expansion and contraction. Although the spring member10 is shown with six windings 12, it will be understood that fewer ormore windings can be used. The number of windings 12 will depend on thetype of material used, the thickness of the material and the overallwidth of the spring member 10 when it is contracted for insertion intothe uterus. Since the opening of the cervical canal will usually measureabout 2 to 4 mm. the length of the spring member 10 when fullycontracted and measured parallel to the axis 17 of expansion andcontraction should not exceed this measurement for otherwise it will bevery dilfcult to insert the spring member into the uterus and mayrequire dilating the cervical canal. It has been found that when thespring member is constructed of .020 gauge stainless steel, six windingsgive excellent contraceptive control, are securely retained in theuterus, and the above-defined length measures only 1.5 mm. which can beeasily inserted and passed through the cervical canal. Fewer or morecoils can be used depending on the choice of gauge of the material fromwhich the spring member 10 is constructed, for example, if the materialhas a gauge of .018, seven or eight windings can be used and if it has agauge of .022 four or five windings can be used.

The minimum number of windings is that number which can utilize theuterine contractions for holding the spring member securely in place inthe uterus. Thus, the spring member, it has been found, must have atleast 1 /2 windings 12 or three arms (14, 16), taking a pair of arms 14and 16 as one winding.

The distance between each pair of arms 14 and 16, measured perpendicularto the axis 17 of expansion and contraction, is limited to apredetermined value as previously mentioned to permit the spring member10 to be inserted through the cervical canal without difliculty after ithas been fully contracted. In the embodiment shown in FIG. 1, thisdistance measures 1.5 mm.

Referring again to FIG. 1, the terminal portions 20 of the outer arms 14and 16 of the spring member 10 are turned upward to form closed loops22. The ends of the loops are then attached to the arms 14 and 16 at 24so as to preclude any rough or sharp edges on the spring member 10 anddamage to the uterine walls. A draw string 26, such as Dacron, is passedthrough loops 22 and through the windings 12 and tied at 28 to form aclosed loop 30.

The spring member 10 is inserted into a uterus 32 and positioned so thatthe windings 12 expand between the sides 34 of the uterus as shown inFIG. 2. This is done by contracting or compressing the spring member 10into the uterus, preferably with the aid of a conventional cannula withplunger or by any other conventional apparatus of this type. The springmember 10 is placed in the cervico-isthmal region 36 and 38 of theuterus 32 and then expands against the sides of this region of theuterus.

As a result, the cervico-isthmal region 36 and 38 will start to contractand exert pressure against the lower portions of the windings 12 tocompress the windings together. The spring member 10 will resist beingcompressed which results in a camming action that moves the springmember into the corpus region 40 .of the uterus 32 and up against thefundus 42. When the muscles of the cervicoisthmus region 36 and 38relax, the muscle fibers of the fundus will start to contract. Thecontraction of the fundus muscles will exert pressure against the topportions of the windings 12 of the spring member to compress theseportions together which will cause the bottom portions of the windingsto spread apart as shown in FIG. 3.

The muscular contractions of the fundus will also force the springmember 10 in a downward direction into the cervico-isthmal region 36 and38. However, since the bottom portions of the windings 12 are spread,the windings will not fit through the cervical canal and therefore thespring member 10 will remain in the uterus. After the fundus musclesrelax the muscles of the cervico-isthmus region will start to contractand the above described process is repeated.

As explained above the arms 14 and 16 forming the windings 12 trace animaginary rectangular solid. The spring member 10 therefore has a volumeof predetermined width measuring across each pair of arms 14 and 16,perpendicularly to the axis 17 of expansion and contraction. Since thefront and back walls of the uterus 32 are planar and in contact witheach other, the spring member will separate these walls by approximately1 or 2 mm. corresponding to the predetermined width. It is apparentlybecause of this separation and the fact that relatively more of theuterine cavity is filled with the spring member 10 that materiallybetter contraceptive control is achieved than in conventional devices.

When it is desired to remove the spring member from the uterus, aconventional hooked instrument (not shown) is inserted into the uterusto catch the string 26. The string is then pulled which will compressthe bottom portion of the windings 12 and cause the compressed springmember to easily pass through the cervical canal and out through thevagina.

In a preferred embodiment, one end of a string 44 is attached to the endof loop 30 and the string has suflicient length to extend out beyond theuterus as shown in FIG. 3. This will eliminate the necessity of using aninstrument for removing the spring member. The physician need only pullthe string 44 by hand which will collapse the windings 12 to remove thespring member 10 from the uterus.

It will be clear from the foregoing description that the inventionprovides an intra-uterine contraceptive device which is retained in theuterus by means of the uterine contractions, can readily be inserted andremoved from the uterus without requiring dilation of the cervicalcanal. It is intended to cover all changes and modifications of thepreferred form of structure herein chosen for the purpose ofillustration which do not constitute departures from the spirit andscope of the invention.

I claim:

1. An intra-uterine contraceptive device comprising a flattened spiralspring member of resilient material having a plurality of windings whichare capable of expanding and contracting, said windings tracing athree-dimensional volume of a generally rectangular shape which containsa central axis of expansion and contraction, said windings beingexpandable and contractable along axes which are generally parallel tosaid central axis, the distance between opposite windings measuredperpendicularly to said central axis and the distance between the endsof said windings when contracted being such that said spring member whenso contracted may be passed through the cervical canal of the user ofthe device for emplacement and subsequent expansion within the uterus.

2. An intra-uterine contraceptive device as in claim 1 wherein saiddistance measured perpendicular to said axis is such that said devicewhen collapsed may be passed through said cervical canal without havingto dilate said canal.

3. An intra-uterine contraceptive device as in claim 1 wherein saiddistance between the ends of said contracted windings measured parallelto said axis may be passed through said cervical canal without having todilate said canal.

4. The intra-uterine contraceptive device of claim 1 wherein thedistance between opposite windings measured perpendicular to said axisis not greater than about 4.5 mm. and the distance between the ends ofsaid contracted windings measured parallel to said axis is not greaterthan about 4.5 mm.

5. An intra-uterine contraceptive device comprising a spring member ofresilient material having a plurality of windings in a configurationanalogous to a flattened spiral spring, said windings tracing athree-dimensional volume of a generally rectangular shape containing acentral axis of expansion and contraction, said windings beingexpandable and contractable along axes generally parallel to saidcentral axis, the distance between opposite windings measuredperpendicularly to said central axis and the distance between the endsof said windings when contracted having pre-determined values, saiddevice being constructed and arranged for emplacement in the uterus bypassing the device in contracted position through the cervical canal ofthe intended user without having to dilate said canal.

6. The intra-uterine contraceptive device of claim 5 wherein thedistance between opposite windings measured perpendicularly to saidcentral axis and the distance between ends of said winding whencontracted are each from about 1 mm. to about 3 mm.

7. The intra-uterine contraceptive device of claim 4 wherein the saidspring member is made from spring tempered stainless steel.

8. The intra-uterine contraceptive device of claim 4 wherein a string ispassed through the said windings for removing said spring member fromthe uterus.

9. The intra-uterine contraceptive device of claim 8 wherein the saidstring is of suflicient length to extend out from the uterus.

References Cited UNITED STATES PATENTS 1,896,071 2/1933 Clark 128-1303,200,815 8/1965 Margulies 128-130 3,323,520 6/1967 Hall 128-1303,250,271 5/1966 Lippes 128-130 ADELE M. EAGER, Primary Examiner.

1. AN INTRA-UTERINE CONTRACEPTIVE DEVICE COMPRISING A FLATTENED SPIRAL SPRING MEMBER OF RSILIENT MATERIAL HAVING A PLURALITY OF WINDINGS WHICH ARE CAPABLE OF EXPANDING AND CONTRACTING, SAID WINDINGS TRACKING A THREE-DIMENSIONAL VOLUME OF A GENERALLY RECTANGULAR TRACING A THREE-DIMENSIONAL CENTRAL AXIS OF EXPANSION AND CONTRACTION, SAID WINDINGS BEING EXPANDABLE AND CONTRACTABLE ALONG AXES WHICH ARE GENERALLY PARALLEL TO SAID CENTRAL AXIS, THE DISTANCE BETWEEN OPPOSITE WINDINGS MEASURED PERPENDICULARLY TO SAID CENTRAL AXIS AND THE DISTANCE BETWEEN THE ENDS OF SAID WINDINGS WHEN CONTRACTED BEING SUCH THAT SAID SPRING MEMBER WHEN SO CONTRACTED MAY BE PASSED THROUGH THE 